NCT03479073

Brief Summary

To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

March 6, 2018

Last Update Submit

June 14, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of stroke or systemic embolism after AF ablation

    Risk factors for stroke or systemic embolism after AF ablation

    From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)

Study Arms (2)

Stroke group

Patients who experienced stroke or systemic embolic event following catheter ablation for AF.

Control group

Patients who did not experienced stroke or systemic embolic event following catheter ablation for AF.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population was extracted from a consortium of registry of AF ablation by three University Hospitals (Korea univ Guro, Korea univ Anam and Seoul National University) from 1998 to 2016.

You may qualify if:

  • Patients who underwent catheter ablation for AF

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Ahn J, Shin SY, Shim J, Kim YH, Han SJ, Choi EK, Oh S, Shin JY, Choe JC, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Lip GYH, Lim HE. Association between epicardial adipose tissue and embolic stroke after catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2209-2216. doi: 10.1111/jce.14154. Epub 2019 Sep 19.

    PMID: 31502330DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 27, 2018

Study Start

May 17, 2017

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

KR(3)